(30 days)
The XLTEK Connex Headbox works in conjunction with Excel Tech Sleep software. This Connex headbox is used to acquire and review sleep recordings (polysomnography) in research or clinical environments for:
- Digital recording of high-level output signals (such as EEG, respiratory and oximetry . signals) from conventional polygraphic recorders, signal transducers or amplifiers.
- Selection of recorded signal sections for on-screen review, annotation and marking of . sleen stages.
- Computer-assisted event marking and quantitative analysis of EEG, respiratory and . oximetry signals.
- Computer-assisted reporting of simple measures obtained from the recorded signals (such . as magnitude, time and frequency and simple statistical measures of marked events)
The Connex is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intraoperative settings.
The Connex requires competent user input, and its output must be reviewed and interpreted by trained polysomnographers or trained medical professionals who will exercise professional judgment in using this information.
The Connex does not make any judgment of normality of the displayed signals or the result of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
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I apologize, but the provided text is a legally focused document (an FDA 510(k) clearance letter) and does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or specific details about standalone or MRMC studies.
The document primarily focuses on:
- Granting substantial equivalency for the XLTEK Connex device.
- Listing the regulatory classification and product codes.
- Outlining general regulatory compliance requirements for the manufacturer.
- Stating the intended use (Indications for Use) of the device, which is for acquiring and reviewing sleep recordings (polysomnography) in research or clinical environments. It also specifies its limitations (e.g., not for critical care or intraoperative settings).
Therefore, I cannot extract the table of acceptance criteria, study details, or other specific performance metrics as they are simply not present in this document.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).